Drug product
CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
D-1304-2019
Product summary
- Firm
- Unipharma, Llc.
- Event
- Event 82754
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23712 cartons
- Official record key
drug-enforcement:D-1304-2019
Official wording
Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Code information: Lots: 80026 Exp. 05/31/20; 80027 Exp. 07/31/20
Distribution pattern: Nationwide and Venezuela
Derived failure modes
-
Manufacturing or process control
CGMP Deviations